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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01012-1
Product Name/Description Cook Beacon Tip Angiography Catheters

Beacon Tip Torcon NB Advantage Catheters
Catalogue Prefix: HNBR4.0, HNBR4.1 and only HNBR5.0 w/RUC Suffix

Beacon Tip Royal Flush Plus High-Flow Catheters
Catalogue Prefix: HNR4.0

Slip-Cath Beacon Tip Catheters
Catalogue Prefix: SCBR4.0, SCBR4.1, and only SCBR5.0 w/RUC Suffix

Shuttle Select Slip-Cath, 4 FR Shuttle System Compatible
Catalogue Prefix: SCBR4.5

Multiple Lot Numbers affected

ARTG Numbers: 137861, 154909, 154911, 137865
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 14/10/2015
Responsible Entity William A Cook Australia Pty Ltd
Reason/Issue Cook Medical is initiating a recall of all lots in distribution following reports of catheter tip splits and/or separation. Potential adverse events that may occur as a result of catheter tip splitting and or separation may include the loss of device function, medical intervention to retrieve the separated segment, or complications resulting from the separated tip occluding blood flow to end organs.
Recall Action Recall
Recall Action Instructions Cook Medical is advising users to inspect and quarantine any affected lots for return to Cook Medical.
Contact Information 1800 777 222 - Cook Medical